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Title: Wear-Off of OnabotulinumtoxinA Effect Over the Treatment Interval in Chronic Migraine: A Retrospective Chart Review With Analysis of Headache Diaries.
Austin Authors: Ruscheweyh, Ruth;Athwal, Bal;Gryglas-Dworak, Anna;Frattale, Ilaria;Latysheva, Nina;Ornello, Raffaele;Pozo-Rosich, Patricia;Sacco, Simona;Torres Ferrus, Marta;Stark, Catherine D 
Affiliation: Department of Neurology, Ludwig Maximilians University Munich, München, Germany
Headache Unit, Neurology Department, Vall d'Hebron University Hospital, Barcelona, Spain
Department of Neurology, Royal Free Hospital, London, UK
Headache and Neurological Pain Research Group, Vall d'Hebron Research Institute, Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain
Department of Pediatrics and Rare Diseases, Headache Center Wroclaw, Wroclaw Medical University, Wroclaw, Poland
Department of Neurology, Institute for Postgraduate Education, First Moscow State Medical University (Sechenov University), Moscow, Russia
Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, L'Aquila, Italy
Issue Date: Sep-2020
Date: 2020-08-14
Publication information: Headache 2020; 60(8): 1673-1682
Abstract: To quantify wear-off of the response to OnabotulinumtoxinA (OnabotA) treatment over the treatment cycle in chronic migraine at group and individual level. OnabotA administered quarterly is an effective treatment for chronic migraine. However, some patients report that headache recurs before the scheduled follow-up injection. In this retrospective chart review performed in 6 university outpatient centers or private practices specialized in headache treatment, 112 patients with a ≥30% response to OnabotA who completed headache diaries over 13 weeks after OnabotA treatment were included (age [mean ± SD] 45 ± 12 years, 82% female, headache days/month at baseline 24 ± 6). Compared to weeks 5 to 8 after injection, headache days/week increased significantly in weeks 12 (+0.52 ± 1.96, 95% CI [0.15, 0.88], P < .009) and 13 (+1.15 ± 1.95, CI[0.79, 1.52], P < .001), demonstrating significant wear-off of the OnabotA effect. Similarly, acute medication days/week significantly increased in weeks 12 (0.38±1.67, CI [0.06, 0.69], P ≤ .027) and 13 (+0.83 ± 1.76, CI [0.49, 1.16], P < .001). At an individual level, 57 patients (51%) showed ≥30% wear-off by weeks 12 and 13, and 28 patients (25%) showed ≥30% wear-off already by weeks 10 and 11. Age, gender, OnabotA dose or cycle number, or headache center did not predict individual wear-off. These data show that in clinical practice, on average the response of chronic migraine patients to OnabotA injection shows a clinically significant wear-off from week 12 after treatment. About 25% of the patients experience wear-off even by weeks 10 and 11. It must be noted that wear-off detected in a real-world study on OnabotA responders can be due to wear-off of a pharmacological OnabotA effect or a placebo effect, or to regression to the mean effects. This wear-off phenomenon may negatively affect quality of life of chronic migraine patients under OnabotA treatment. The best way to counteract wear-off remains to be determined.
DOI: 10.1111/head.13925
ORCID: 0000-0001-9510-7158
Journal: Headache
PubMed URL: 32797631
Type: Journal Article
Subjects: OnabotulinumtoxinA
botulinum toxin
chronic migraine
time course
treatment cycle
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